Cook Robert W, Middlebrook Brooke, Wilkinson Jeff, Covington Kyle R, Oelschlager Kristen, Monzon Federico A, Stone John F
Castle Biosciences, Inc., 820 S. Friendswood Dr., Suite 201, Friendswood, TX, 77546, USA.
, 3737 N. 7th St. #160, Phoenix, 85014, Phoenix, USA.
Diagn Pathol. 2018 Feb 13;13(1):13. doi: 10.1186/s13000-018-0690-3.
The DecisionDx-Melanoma test provides prognostic information for patients with cutaneous melanoma (CM). Using formalin-fixed paraffin-embedded primary tumor tissue, the RT-PCR-based test classifies patients into a low- (Class 1) or high-risk (Class 2) category for recurrence based on expression of 31 genes. The current study was designed to assess the analytical validity of this test.
Inter-assay, inter-instrument, and inter-operator studies were performed to evaluate reliability of the 31-gene expression test results, sample stability and reagent stability. From March 2013 through June 2016, the gene expression test was performed on 8244 CM tumors. De-identified data from Pathology Reports were used to assess technical success.
Robust sample and reagent stability was observed. Inter-assay concordance on 168 specimens run on 2 consecutive days was 99% and matched probability scores were significantly correlated (R = 0.96). Inter-instrument concordance was 95%, and probability scores had a correlation R of 0.99 (p < 0.001). From 8244 CM specimens submitted since 2013, 85% (7023) fulfilled pre-specified tumor content parameters. In these samples with sufficient tumor requirements, the technical success of the test was 98%.
DecisionDx-Melanoma is a robust gene expression profile test that demonstrates strong reproducibility between experiments and has high technical reliability on clinical samples.
DecisionDx - 黑色素瘤检测可为皮肤黑色素瘤（CM）患者提供预后信息。该基于逆转录聚合酶链反应（RT-PCR）的检测使用福尔马林固定石蜡包埋的原发性肿瘤组织，根据31个基因的表达情况将患者分为复发低风险（1类）或高风险（2类）类别。本研究旨在评估该检测的分析有效性。
进行了批间、仪器间和操作人员间研究，以评估31基因表达检测结果的可靠性、样本稳定性和试剂稳定性。2013年3月至2016年6月，对8244例CM肿瘤进行了基因表达检测。利用病理报告中的去识别数据评估技术成功率。
观察到样本和试剂稳定性良好。连续两天检测的168个样本的批间一致性为99%，匹配概率得分显著相关（R = 0.96）。仪器间一致性为95%，概率得分的相关性R为0.99（p < 0.001）。自2013年提交的8244例CM标本中，85%（7023例）满足预先设定的肿瘤含量参数。在这些满足肿瘤要求的样本中，该检测的技术成功率为98%。
DecisionDx - 黑色素瘤是一种可靠的基因表达谱检测方法，在实验之间具有很强的可重复性，对临床样本具有很高的技术可靠性。
